MAUDE Adverse Event Report: COOK INC COOK SPECTRUM TURBO-JECT; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient received a spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc on (b)(6) 2017 for unspecified treatment.The picc line broke on the extension tubing beneath the white end cap hub during device maintenance on (b)(6) 2017.The device was explanted and replaced.The handling conditions and circumstances surrounding the event are not known.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, dimensional verification, drawings, instructions for use (ifu), manufacturing instructions, quality control data, and visual inspection was conducted during the investigation.The product was returned in the damaged condition.The device appears to have been cut beyond the hub.Catheter length beyond the hub measures 42 mm from the manifold hub.The extension tube is cracked and mostly separated at the location of the white luer hub connection.Closure clamps on the extension tubes have left deep impressions after being released.Additional similar impressions in the extension tubes resemble those left by the clamps.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.It is possible based on the provided information that the root cause of this event is related to the forces experienced by the extension tubes of the catheter where tubes join the luer hub, however we do not have enough evidence to identify a definitive root cause at this time.Appropriate measures have been initiated to address this failure mode.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: COOK SPECTRUM TURBO-JECT
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6720789
• Report Number: 1820334-2017-01629
• Device Sequence Number: 11163276
• Product Code: LJS
• UDI-Device Identifier: 00827002345454
• UDI-Public: (01)00827002345454(17)180831(10)7421913
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-4.0-CT-40NT-ABRM-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR